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K Number
K983423
Device Name
THE APTUS (AUTOMATED) APPLICATION OF THE SCL-70 ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE
Manufacturer
ZEUS SCIENTIFIC, INC.
Date Cleared
1998-11-18

(50 days)

Product Code
LLL
Regulation Number
866.5100
Type
Traditional
Panel
Immunology
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Scl-70 ELISA test system is intended for the manual or automated analysis of human serum for the presence of IgG antibodies Scl-70.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a device called "Aptus (Automated) Application for the Scl-70 Test System". However, it is a regulatory document and does not contain the detailed study results, acceptance criteria, or performance data that would be found in a clinical study report or a more comprehensive summary of safety and effectiveness.

Therefore, I cannot extract the specific information requested in your prompt regarding acceptance criteria and study details. The document primarily states that the device is "substantially equivalent" to legally marketed predicate devices and is thus permitted to be marketed.

To provide the requested information, I would need a different type of document, such as:

  • 510(k) Summary of Safety and Effectiveness: This document, often submitted with the 510(k) application, would typically contain the study design, acceptance criteria, and performance results.
  • Clinical Study Report: A detailed report of the clinical trials conducted.
  • Labeling or Instructions for Use (IFU): Sometimes, performance characteristics are summarized in these documents.

Based only on the provided text, here's what I can state:

  • Acceptance Criteria and Reported Device Performance: Not available in this document.
  • Sample size used for the test set and the data provenance: Not available.
  • Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
  • Adjudication method: Not available.
  • If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not available.
  • If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not available.
  • The type of ground truth used: Not available.
  • The sample size for the training set: Not available.
  • How the ground truth for the training set was established: Not available.

The document only indicates the "Scl-70 ELISA test system is intended for the manual or automated analysis of human serum for the presence of IgG antibodies Scl-70." For the detailed performance characteristics, the actual 510(k) submission or a related scientific publication would be required.

§ 866.5100 Antinuclear antibody immunological test system.

(a)
Identification. An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents (molecules present in the nucleus of a cell, such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins). The measurements aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim's own tissues), hepatitis (a liver disease), rheumatoid arthritis, Sjögren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues).(b)
Classification. Class II (performance standards).